Novartis announced today that Exelon(R)
(rivastigmine tartrate) has been granted European marketing authorization
by the European Commission for the symptomatic treatment of mild to
moderately severe dementia in patients with idiopathic Parkinson’s disease
(PD) in all 25 European member states.
This makes Exelon, currently indicated for Alzheimer’s dementia, the first
medication available to treat dementia in Parkinson’s patients in the
European Union and the only cholinesterase inhibitor to be authorized for
more than one type of dementia. Exelon has already received marketing
authorization for dementia associated with PD in Switzerland and several
Latin American countries, including Brazil.
The EU approval is based on the results of the EXPRESS study, a
large-scale, randomized, well-controlled study involving 541 patients from
12 study centers in Europe and Canada and follows the positive opinion
granted by the Committee for Medicinal Products for Human Use (CHMP)
earlier this year.
“Exelon provides an important advance in the therapy of dementia associated
with Parkinson’s disease”, said Professor Werner Poewe, Head of Neurology,
University Hospital, Innsbruck, Austria. “In the EXPRESS study, patients
taking Exelon showed significant benefits regarding memory, concentration
and behavioral problems. Patients and their caregivers reported in
particular an increased interest and ability to conduct social
conversations. This does not only translate into a better quality of life
for PD patients suffering from dementia but also a substantial improvement
in the quality of life for their families,” Werner Poewe concluded.
At any one time, up to 40 percent of people with Parkinson’s disease suffer
from dementia . Patients with dementia associated with Parkinson’s disease
typically have problems with memory, concentration, activities of daily
living, as well as depression, anxiety, apathy and hallucinations .
However, probably due to the absence of treatment, current diagnosis rates
“When my husband developed dementia associated with Parkinson’s disease, I
became a nervous wreck. He would ask me the same question again and again
and again,” said
Mrs I., spouse of PD patient suffering from dementia. “Since he has started
taking this new medicine he pays more attention, we have conversations and
he can go to the shop by himself. It is wonderful. I know it won’t go away
completely, but these tablets have really changed our lives. Everything is
About the EXPRESS study
The regulatory submissions were based on the EXPRESS study (EXelon in
PaRkinson’s disEaSe dementia Study), published in December 2004 in the New
England Journal of Medicine . EXPRESS is the first large-scale clinical
study assessing the efficacy and safety of any treatment in Parkinson’s
disease patients with dementia. Patients taking Exelon showed statistically
significant benefits on a range of symptoms, such as maintaining or
improving memory, concentration and behavioral problems. They were also
able to cope better with everyday activities like watching TV or talking
about current events.
The side effects associated with Exelon during this study were mild to
moderate in nature and included nausea and vomiting. Importantly, motor
scale assessments showed that Parkinsonian symptoms were not worsened
overall relative to baseline or placebo. Mild to moderate tremor was
reported in 10% of Exelon-treated patients, but this resulted in relatively
few withdrawals from the study.
Since 1997, Exelon has been widely used to treat mild to moderately severe
Alzheimer’s dementia in over 70 countries. It belongs to a class of drugs
known as cholinesterase inhibitors (ChEI’s) which increase the activity of
the neurotransmitter acetylcholine in the brain.
Among the ChEI’s, Exelon is the only treatment that inhibits both enzymes
involved in the breakdown of this neurotransmitter – acetylcholinesterase
(AChE) and butyrylcholinesterase (BuChE). This may offer additional
benefits over treatments which inhibit AChE alone. Exelon can maintain both
memory and thinking, help with behavioral problems and affect how patients
cope with the activities of daily living. It may help them communicate
better, interact socially, participate in hobbies and in activities of
About Parkinson’s Disease Dementia
Parkinson’s disease is a chronic and progressive neurological condition
estimated to affect 6.3 million people worldwide . Dementia is thought to
occur in up to 40 percent of patients diagnosed with this disease and may
affect up to 80 percent of Parkinson’s patients in advanced age and severe
diseaseError! Bookmark not defined.1, . Parkinson’s patients have a
six-fold increase in the risk of developing dementia compared with elderly
people without Parkinson’s disease.
Like Alzheimer’s, dementia associated with Parkinson’s disease is thought
to result partly from a cholinergic deficit, which causes decreased
transmission of signals between nerves in the brain, especially those that
rely on the neurotransmitter acetylcholine.
Dementia associated with Parkinson’s disease differs clinically from
Alzheimer dementia. Patients with dementia associated with Parkinson’s
disease generally suffer from an impairment of executive function like the
ability to plan or organize and goal-directed behavior. Furthermore they
have more severe visuospatial deficits, apathy, severe attentional deficits
with fluctuations and frequent visual hallucinations.
This release contains certain forward-looking statements relating to the
Company’s business, which can be identified by the use of forward-looking
terminology such as “may offer”, “may help”, “goal is”, or similar
expressions, or by express or implied discussions regarding potential new
indications for Exelon, or regarding potential future revenue from Exelon.
Such forward-looking statements involve known and unknown risks,
uncertainties and other factors that may cause actual results with Exelon
to be materially different from any future results, performance or
achievements expressed or implied by such statements. There can be no
guarantee that Exelon will be approved for any additional indications in
any market or regarding potential future revenue from Exelon. In
particular, management’s expectations regarding commercialization of Exelon
could be affected by, among other things, additional analysis of Exelon
clinical data; new clinical data; unexpected clinical trial results;
unexpected regulatory actions or delays in government regulation generally;
the company’s ability to obtain or maintain patent or other proprietary
intellectual property protection; competition in general; government,
industry, and general public pricing pressures; as well as factors
discussed in the Company’s Form 20-F filed with the US Securities and
Exchange Commission. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those described herein as anticipated,
believed, estimated or expected. Novartis is providing the information in
this press release as of this date and does not undertake any obligation to
update any forward-looking statements contained in this press release as a
result of new information, future events or otherwise.
Novartis has been a leader in the neuroscience area for more than 50 years,
having pioneered early breakthrough treatments for Alzheimer’s disease,
Parkinson’s disease, attention deficit/hyperactivity disorder, epilepsy,
schizophrenia and migraine. Novartis continues to be active in the research
and development of new compounds, is committed to addressing unmet medical
needs and to supporting patients and their families affected by these
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health, treat disease and improve well-being. Our goal is to discover,
develop and successfully market innovative products to treat patients, ease
suffering and enhance the quality of life. Novartis is the only company
with leadership positions in both patented and generic pharmaceuticals. We
are strengthening our medicine-based portfolio, which is focused on
strategic growth platforms in innovation-driven pharmaceuticals,
high-quality and low-cost generics and leading self-medication OTC brands.
In 2005, the Group’s businesses achieved net sales of USD 32.2 billion and
net income of USD 6.1 billion. Approximately USD 4.8 billion was invested
in R&D. Headquartered in Basel, Switzerland, Novartis Group companies
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the world. For more information, please visit novartis.
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